[Federal Register Volume 78, Number 215 (Wednesday, November 6, 2013)]
[Notices]
[Pages 66743-66744]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-26570]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2007-D-0369]


Draft Guidance for Industry on Bioequivalence Recommendations for 
Iron Sucrose; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a draft guidance for industry entitled ``Bioequivalence 
Recommendations for Iron Sucrose.'' The recommendations provide 
specific guidance on the design of bioequivalence (BE) studies to 
support abbreviated new drug applications (ANDAs) for iron sucrose 
injection. The draft guidance is a revised version of a previously 
issued draft guidance on the same subject.

DATES: Although you can comment on any guidance at any time (see 21 CFR 
10.115(g)(5)), to ensure that the Agency considers your comments on 
this draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by January 6, 2014.

ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Division of Drug Information, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 2201, Silver Spring, MD 20993-0002. Send 
one self-addressed adhesive label to assist that office in processing 
your requests. See the SUPPLEMENTARY INFORMATION section for electronic 
access to the draft guidance document.
    Submit electronic comments on the draft guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Kris Andre, Center for Drug Evaluation 
and Research (HFD-600), Food and Drug Administration, 7520 Standish 
Pl., Rockville, MD 20855, 240-276-8866.

SUPPLEMENTARY INFORMATION: 

I. Background

    In the Federal Register of June 11, 2010 (75 FR 33311), FDA 
announced the availability of a guidance for industry entitled 
``Bioequivalence Recommendations for Specific Products,'' which 
explained the process that would be used to make product-specific BE 
recommendations available to the public on FDA's Web site at http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm. As described in that guidance, FDA adopted this process as 
a means to develop and disseminate product-specific BE recommendations 
and provide a meaningful opportunity for the public to consider and 
comment on those recommendations. This notice announces the 
availability of draft BE recommendations for iron sucrose injection 
(Draft Iron Sucrose Injection BE Recommendations of 2013).
    Venofer (iron sucrose injection), new drug application 021135, was 
initially approved by FDA in November 2000. There are no approved ANDAs 
for this product.
    In March 2012, FDA posted on its Web site a draft guidance for 
industry on the Agency's recommendations for BE studies to support 
ANDAs for iron sucrose injection (Draft Iron Sucrose Injection BE 
Recommendations of 2012). In that draft guidance, FDA recommended an in 
vivo fasting BE study with pharmacokinetic endpoints and in vitro 
studies. FDA has reconsidered the recommendations in the Draft Iron 
Sucrose Injection BE Recommendations of 2012 and has decided to revise 
it. At this time, FDA is withdrawing the Draft Iron Sucrose Injection 
BE Recommendations of 2012 and is issuing a revised draft guidance for 
industry, the Draft Iron Sucrose Injection BE Recommendations of 2013. 
In this revised draft guidance, FDA recommends that for the in vivo 
pharmacokinetic study the difference between total iron and 
transferrin-bound iron be used to demonstrate BE of generic iron 
sucrose injection products. FDA is no longer recommending baseline-
adjusted total iron and baseline-adjusted transferrin-bound iron be 
used to demonstrate BE of generic iron sucrose injection products. The 
revised draft guidance also provides updated information about the 
recommended studies for in vitro characterization and criteria for 
waiver of in vivo testing.
    In March 2005, Luitpold Pharmaceuticals, Inc. (Luitpold), 
manufacturer of the reference listed drug, Venofer, submitted (through 
its attorneys) a citizen petition requesting that FDA withhold approval 
of any ANDA or 505(b)(2) application for a generic iron sucrose 
injection unless certain conditions were satisfied, including 
conditions related to demonstrating BE (Docket No. FDA-2005-P-0319, 
formerly 2005P-0095/CP1). FDA is reviewing the issues raised in the 
petition and is also reviewing the supplemental information and 
comments that have been submitted to the docket for that petition. FDA 
will consider any comments on the Draft Iron Sucrose Injection BE 
Recommendations of 2013 before responding to Luitpold's citizen 
petition.
    This draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The draft guidance, when 
finalized, will represent the Agency's current thinking on the design 
of BE studies to support ANDAs for iron sucrose injection. It does not 
create or confer any rights for or on any person and does not operate 
to bind FDA or the public. An alternative approach may be used if such 
approach satisfies the

[[Page 66744]]

requirements of the applicable statutes and regulations.

II. Comments

    Interested persons may submit either electronic comments regarding 
this document to http://www.regulations.gov or written comments to the 
Division of Dockets Management (see ADDRESSES). It is only necessary to 
send one set of comments. Identify comments with the docket number 
found in brackets in the heading of this document. Received comments 
may be seen in the Division of Dockets Management between 9 a.m. and 4 
p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov.

III. Electronic Access

    Persons with access to the Internet may obtain the document at 
either http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or http://www.regulations.gov.

    Dated: October 31, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-26570 Filed 11-5-13; 8:45 am]
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